Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-02-28 @ 9:31 AM
Study NCT ID:
NCT05323058
Status:
UNKNOWN
Last Update Posted:
2022-05-11
First Post:
2022-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013280', 'term': 'Stomatitis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713370', 'term': 'holy basil leaf extract'}, {'id': 'D001591', 'term': 'Benzydamine'}], 'ancestors': [{'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The principal investigator and participant will be blinded as the treatment preparations will be identical in color, odor, and consistency and they will be placed in identical bottles'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Allocation ratio (1:1)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-06', 'studyFirstSubmitDate': '2022-03-27', 'studyFirstSubmitQcDate': '2022-04-04', 'lastUpdatePostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Oral Assessment Guide (OAG)', 'timeFrame': 'up to 15 days', 'description': 'Assessment of patient speech, salivary function and quality, gingival health, swallowing, lips, and oral hygiene.'}, {'measure': 'Patient-Reported Oral Mucositis( PROMS scale)', 'timeFrame': 'up to 15 days', 'description': 'Quality of life'}], 'primaryOutcomes': [{'measure': 'Severity of mucositis', 'timeFrame': 'up to 15 days', 'description': 'Oral Mucositis Assessment Scale (OMAS)'}], 'secondaryOutcomes': [{'measure': 'Pain and burning sensation', 'timeFrame': 'up to 15 days', 'description': 'assess by numerical rating scale (NRS) (10 points scale)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral mucositis', 'tulsi extract', 'benzydamine hydrochloride', 'radiotherapy'], 'conditions': ['Stomatitis']}, 'descriptionModule': {'briefSummary': 'After signing the informed consent, the participant will be allocated to either intervention or control group, then each participant will use either 0.15% benzydamine (Comparator) or 4% tulsi (Intervention) four times a day and also once half an hour before each radiotherapy session.', 'detailedDescription': 'the primary outcome is the severity of oral mucositis will assess by Oral Mucositis Assessment Scale (OMAS) and secondary outcomes are pain will assess Numerical rating scale (NRS), Oral Assessment Guide (OAG), and Patient-Reported Oral Mucositis( PROMS scale) All outcomes will be recorded at baseline, and 8, 15 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having clinical signs of radiotherapy-induced OM (WHO oral mucositis grading scale: Grade II, III, and IV)\n* Patient should be able to read and/or understand and sign the consent form.\n\nExclusion Criteria:\n\n1. Patients with HIV infections or hyperthyroidism.\n2. Karnofsky performance status (KPS) less than 60%\n3. Patients having an allergy to tulsi or benzydamine HCL\n4. Patients who are pregnant and/or nursing.'}, 'identificationModule': {'nctId': 'NCT05323058', 'briefTitle': 'The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'tulsi in radiation mucositis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tulsi extract', 'description': '4% tulsi extract as intervention', 'interventionNames': ['Drug: tulsi extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'benzydamine hydrochloride', 'description': '0.15% benzydamine hydrochloride', 'interventionNames': ['Drug: Benzydamine Hydrochloride']}], 'interventions': [{'name': 'tulsi extract', 'type': 'DRUG', 'description': '4% topical oral spray', 'armGroupLabels': ['tulsi extract']}, {'name': 'Benzydamine Hydrochloride', 'type': 'DRUG', 'description': '0.15% topical oral spray', 'armGroupLabels': ['benzydamine hydrochloride']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Karima AbdAllah Kamel, PhD', 'role': 'CONTACT', 'email': 'karima.kamel@dentistry.cu.edu.eg', 'phone': '+201014875386'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Karima AbdAllah Kamel', 'investigatorAffiliation': 'Cairo University'}}}}